Full trial enrollment?


Positive trial results?


Cytosorbents Corporation announced that it has received CE Mark approval for CytoSorb for the treatment of conditions "where excessive cytokine levels exist", according to a press release issued during the pre-market hours Thursday.

In very significant fashion, the press release goes on to say:

"This milestone certifies that CytoSorb™ has met the safety and label efficacy claim requirements of the European Medical Devices Directive and can now be sold in the European Union (E.U.) for human clinical use."

In short, the trial that we have all been speculating on, and wondering whether full enrollment has been met, is over and the primary endpoint was met.

Additionally, the treatment was well tolerated, "with no serious device-related adverse effects," which cleared the way for Cytosorbents to market CytoSorb for other conditions, not only just for the treatment of severe sepsis.

The CEO, Dr. Philip Chan said it best - this is the most significant event in the company's history.

CytoSorb will be on the European market during the second half of this year, and being that there will be no competition for treating severe sepsis, and little competition for treating other high-cytokine indications, the product could hit the ground running.

Those that will hang out for the long term will have US FDA approval on the radar, although that is likely still a ways off.

For the short term, the CTSO share price should appreciate in significant fashion.

Keep in mind, however, that to manufacture and market the product, it'll cost money - probably more than what's on hand now - so a cash-raising event may be in store over the short term.

That said, Cytosorbents is in the driver seat now and any deal will come at much more favorable conditions than what they would have been before this news was announced.

Thursday marks a milestone celebratory event for this company and its shareholders, and it's now just a matter of time before CTSO meets its full market potential.

Be aware of volatility and I'm always a fan of taking some money off the table into any significant spikes.

Disclosure: Long CTSO.

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